BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/40MM THRD LGTH

    MDR report key: 2852637 · Received November 30, 2012

    Report

    Report Number
    2530088-2012-01040
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 5, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED APPROXIMATELY 2007 OR 2006. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH CONSTRUCT AT T12 TO L2 APPROXIMATELY 2007 OR 2006. THE PATIENT WAS COMPLAINING OF PAIN; THE SCREWS IN THE THORACIC CURVE ARE PRONOUNCED AND PATIENT'S POSTURE WORSENS DUE TO PROGRESSION OF PRONOUNCED SCREWS. SURGEON RETURNED PATIENT TO THE OR ON (B)(6) 2012. IT WAS NOTED PATIENT WAS FUSED AND THE HARDWARE WAS REMOVED FROM THE RIGHT SIDE, 1 ROD, 3 SCREWS 3 LOCKING CAPS. THE POSTERIOR SIDE WAS LEFT INTACT AND NOT REMOVED, 1 ROD, 2 SCREWS, 2 LOCKING CAPS. THE PROCEDURE WAS COMPLETED. THIS IS 4 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/40MM THRD LGTH POLYAXIAL SCR DUAL CORE NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention ROD, SCREWS, LOCKING CAPS.